medical industry Archives - Means Engineering, Inc.

Recent Changes to IEC 60601-1 Impact Medical Device Manufacturers

December 4, 2020 By meiadmin

When creating devices for the medical industry, it’s crucial that manufacturers take care to ensure the quality, consistency, and reliability of every part produced. This isn’t just important for consumer satisfaction, it’s crucial for the health and safety of those that use these important devices.

Medical devices are regulated by the Food and Drug Administration (FDA). In order to prove compliance, medical device manufacturers must meet the standards for the safety and essential performance of medical electrical equipment.

The internationally recognized standard, IEC 60601, was first published in 1977. Since that time, the standard has been updated and restructured several times. The most recent update to IEC 60601-1 was published earlier this year and includes several changes and clarifications. It’s important that medical device manufacturers learn and understand these changes to ensure compliance.

The most recent amendment, A2:2019, will mark the standard for medical devices for the next few years. The next change is not expected until 2024.

Important Changes to IEC 60601-1

While some of the changes to IEC 60601-1 seem minor, they could result in previously certified devices not meeting the new requirements for compliance. It’s crucial that medical device manufacturers take some time to make themselves familiar with A2:2019.

IEC 60601-1 A2:2019, also known as Version 3.2, includes 78 changes. The most important changes are listed below.

IEC 60601-1 A2:2019 updates out-of-date references to ISO 14971 and IEC 62304
Amendment 2 includes important changes that align IEC 60950-1: A2 and IEC 62368-1 in regards to safety requirements for audio/video, information, and communications technology
A2:2019 includes error rectification and clarifications
The Amendment includes changes affecting the design and layout of medical devices
The Amendment also includes changes to standards for labelling, electrical hazards, mechanical hazards, thermal hazards, hazardous situations and fault conditions, and ME systems.

It’s important to note that these changes apply to both manufacturers and those responsible for testing medical devices and medical device components. Testers can only accept components that comply with IEC 60950-1 until December 20^th, 2020. After this date, in stock medical devices and components can no longer be used.

Medical Device Contract Manufacturing Services

Working with an experienced contract manufacturer can help ensure compliance with FDA requirements. An experienced CM has the tools, experience, and technology needed to keep up with changing regulations.

Means Engineering offers contract manufacturing services to OEMs and organizations in the medical industry. Please contact us for information about our services.

Medical Device Creation – Ensuring a Successful Contract Manufacturing Relationship

November 20, 2020 By meiadmin

Contract manufacturing enables organizations to produce products without the large expense of machinery and technology or the operating costs associated with manufacturing. While contract manufacturing offers numerous benefits to companies across a wide range of industries, there are significant benefits for the medical equipment and device segment.

Strict requirements and the need for machinery capable of creating precision-dependent products often creates a barrier for organizations wishing to enter the medical device industry. These same factors cause many OEMs to leave the market as well. Organizations could benefit from utilizing the help of an experienced medical device contract manufacturer.

Hiring a contract manufacturer allows OEMs to spend less capital, hire fewer employees, spend less time and effort on quality control, and eliminate purchasing hassles. The contract manufacturer handles procurement, production, and testing, allowing the OEM to focus on other important aspects of their business.

Organizations wishing to hire a contract manufacturer should consider it as they would any other long-term business relationship. Before selecting a CM, it’s important to gather as much information as possible.

Selecting a Contract Manufacturer

OEMs should take care to ensure they fully understand the capabilities, strengths, weaknesses, and experience of the contract manufacturer they choose. It’s highly suggested that OEMs develop a list of questions prior to contacting and interviewing each CM. It might also be beneficial for the OEM to contact some of the CM’s customers for feedback.

Process Development

After selecting a contract manufacturer, the development process begins. If this is an existing product being transferred from the OEM, all existing work instructions and raw material sources get shared with the CM at this point. During a series of “knowledge transfer” meetings, the OEM and their staff provide as much information as possible about the manufacturing process. These meetings shouldn’t just include engineers and operators, assembly workers with experience creating the part should be involved as well.

For new products, the contract manufacturer will need to develop the manufacturing process and supply chain. However, it’s still important for the OEM to provide input and knowledge as necessary.

Training & Process Qualification

Once the process is defined, operator training and qualifications begin. Regardless of the type of product, there are standards and optimum processes to adhere to. This is especially true when producing medical devices. These devices face some of the strictest quality standards.

Pilot Builds

The pilot build allows OEMs and contract manufacturers to locate areas that could benefit from improvement. This is the stage when the OEM or CM makes adjustments to the work flows and/or the work instructions.

Entering the Production Phase

Following the pilot build, the CM begins production of the product. It’s crucial that OEMs provide an accurate demand forecast at this point. This helps the CM determine raw material procurement schedules and reorder points.

Means Engineering provides contract manufacturing services for the medical device industry. Please contact us for details.

Outsourcing Allows OEMs to Expand Into New Markets

October 23, 2020 By meiadmin

Companies looking to expand into new markets often face difficult decisions. While most of these organizations understand the benefits of expansion and the potential for increased revenue, many simply aren’t sure how to acquire the equipment, space, and people needed to grow their business. This is especially true for OEMs and other organizations looking to produce parts or products for the medical, defense, or aerospace industries. These industries have strict requirements, and organizations must prove that they have the equipment and skills needed to meet tight tolerances and produce extremely complex devices.

Unfortunately, many organizations avoid expansion or turn down jobs because they do not have the resources needed to complete the work. This can lead to significant loss for the company. In addition to potential loss of revenue, organizations that do not expand will likely fall behind their competition in coming years. This could prove to be especially damaging now, as the world attempts to rebuild the economy. Organizations everywhere will soon be looking for ways to increase earning potential and stability. Expansion into important and essential industries like medical and defense ensures OEMs remain successful even during times of economic downturn.

Outsourcing Reduces Cost and Time to Market

Organizations wishing to expand could benefit from outsourcing part or all of their production to a qualified contract manufacturer like Means Engineering. Outsourcing provides access to experienced individuals, quality equipment and machinery, and state-of-the-art technology at a fraction of the cost of in-house production. Contract manufacturers often have years of experience working with a wide range of industries.

Carlsbad Contract Manufacturing

When you work with Means Engineering, we work directly with your organization to ensure a successful and mutually beneficial relationship. Our team has experience creating complex devices for the medical and defense industries. As an ISO 9001 and ISO 13485 certified contract manufacturer, we understand the unique requirements of these industries and work hard to ensure the quality and consistency of every part produced. Our 5-axis machine allows us to produce extremely complex parts and products.

At Means Engineering, we understand the challenges OEMs face when expanding into new markets. Our team can help you clear this hurdle and ensure the continued success of your company.

Please contact us for information about our contract manufacturing services.

The Importance of ISO 13485 Certification

August 28, 2020 By meiadmin

Organizations responsible for the design and production of medical devices need to understand the strict standards and requirements of government officials. Used for a wide range of applications, medical devices may mean the difference between life and death for those that rely on them. In the United States, medical devices are regulated by the FDA and organizations must receive ISO 13485 certification prior to their design or assembly.

About ISO 13485

ISO 13485:2016 aligns with ISO 9001:2008. It’s important to note that this version of ISO 9001 does not include the same Annex L of the 2015 version. ISO 13485 includes several safety requirements to ensure the quality and reliability of devices created for the medical industry.

Although several countries have their own set of regulations regarding medical device design and creation, ISO 13485 is the main Quality Management System (QMS) standard for medical devices. While organizations in the United States must meet both ISO 13485 and FDA requirements, the FDA plans to eventually harmonize the two.

Despite what many people believe, ISO 13485 is aimed at ensuring high quality products. It is not a standard for products. Instead, ISO 13485 is a process based standard. When followed, these processes ensure a quality end product.

Organizations or businesses receive ISO certification. Individual people cannot become certified in ISO 13485. However, one person in an organization can receive certification as an ISO 13485 Certified Lead Auditor.

Becoming ISO 13485 Certified

Organizations wishing to become ISO 13485 certified must meet strict requirements. This is necessary to ensure the organization fully understands the processes required to create high quality medical devices. Organizations must take all necessary steps to implement an ISO 13485 quality management system. They must then undergo an audit by a Certification Body (CB). If the organization passes the audit, they receive ISO 13485 certification for three years. They must get re-certified after the initial three-year period.

ISO Certified Medical Device Manufacturer

Means Engineering has the people, equipment, and technology needed to produce high quality medical devices. In addition to ensuring the proper practices and standards within our organization, we have taken the steps necessary to become ISO 13485 certified. This puts us in the best possible position to help with the design and production of a wide range of products.

When you work with Means Engineering, you gain access to the knowledge and experience of our highly qualified team. We work directly with our clients to ensure adequate communication throughout the entire process. Please contact us to learn more about our contract manufacturing services for the medical industry.

Choosing an Electronic Contract Manufacturer for Medical Device Creation

July 31, 2020 By meiadmin

Creating devices for the medical industry requires extensive experience and knowledge of industry requirements. Medical devices are highly regulated for both quality and reliability. This is important, as many people rely on the safety and efficiency of medical devices. Perhaps more than any other industry, OEMs planning to produce products for the medical industry should partner with an experienced electronic contract manufacturer.

In addition to understanding how to comply with government regulations, an experienced ECM should meet the following requirements. This can help ensure a successful and mutually beneficial partnership.

Experienced Technical and Managerial Team

The more experienced the electronic contract manufacturer is, the more likely they can help when problems arise. ECMs with experience producing a wide range of devices can often locate problems and suggest viable solutions based on findings from previous projects. In addition to solving problems that arise during production, experienced ECMs can assist with design-for-manufacture review, saving OEMs a considerable amount of time and money on assembly.

Well Maintained Equipment

It’s not enough for an ECM to have quality equipment. They need to properly maintain it to ensure continuous and reliable operation. Calibration of machines and tools should take place at regular intervals.

Proper maintenance not only helps ensure on-time delivery of high quality products, it also allows the ECM to achieve the right tolerance. This is especially important as the medical device industry has stringent tolerance requirements.

Ability to Adjust to Meet Customer Changes

Needs and requirements can change. This is why it’s so important that OEMs select an agile, flexible, and highly responsive ECM to work with.

ISO 13485 Quality Management System

The international standard for a quality management system for the medical device industry, ISO 13485 is designed to be used throughout the entire lifecycle of the medical device. Using ISO 13485, organizations can develop a quality management system that ensures the quality of finished products and the effectiveness of manufacturing processes.

Means Engineering offers electronic manufacturing services for the medical device industry. Our extensive experience and quality management system allows our team to manage risk effectively and bring safe and effective products to market.